Table 1.
Solicited and Unsolicited Symptoms Within the 30-Day Postvaccination Period
| Study Arm | Doses, n | Any Symptom, n (%) | Grade 3, n (%) | With Causal Relationship, n (%) | Grade 3 With Causal Relationship, n (%) | |
|---|---|---|---|---|---|---|
| All doses | ChAd-RSV-LD | 14 | 12 (86) | 1 (7) | 10 (71) | 1 (7) |
| ChAd-RSV-HD | 59 | 53 (90) | 6 (10) | 48 (81) | 2 (3) | |
| Placebo | 38 | 28 (73) | 3 (8) | 21 (55) | 1 (3) | |
| Active | 30 | 30 (100) | 7 (23) | 30 (100) | 6 (20) | |
| Dose 1 | ChAd-RSV-LD | 7 | 7 (100) | 1 (14) | 5 (71) | 1 (14) |
| ChAd-RSV-HD | 31 | 29 (94) | 4 (13) | 27 (87) | 1 (3) | |
| Placebo | 19 | 14 (74) | 3 (16) | 11 (58) | 1 (5) | |
| Active | 15 | 15 (100) | 4 (27) | 15 (100) | 3 (20) | |
| Dose 2 | ChAd-RSV-LD | 7 | 5 (71) | 0 (-) | 5 (71) | 0 (-) |
| ChAd-RSV-HD | 28 | 24 (86) | 2 (7) | 21 (75) | 1 (4) | |
| Placebo | 19 | 14 (74) | 0 (-) | 10 (53) | 0 (-) | |
| Active | 15 | 15 (100) | 3 (20) | 15 (100) | 3 (20) |
The placebo was a saline solution and the active dose was an active control.
Abbreviations: ChAd155, chimpanzee-adenovirus-155 vaccine; HD, high dose; LD, low dose; RSV, respiratory syncytial virus.